Kornimate/medical-research-clean huggingface dataset:
nasal obstruction with oxymetazoline and corticosteroids

Conditions: Nasal Obstruction

Summary: this study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. the investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.

participants will be directed to apply the intranasal spray, at a dosage of two sprays in each nostril, twice daily. the total treatment time for participants in both trial arms is 7 weeks. participants will be randomized to either 1) oxymetazoline + budesonide intranasal spray or 2) budesonide intranasal spray. participants will be mailed the intranasal spray directly from the pharmacy. participants will complete questionnaires via redcap survey link at baseline, week 2, week 4, week 5, week 6, and week 7. a group of 10 participants will be asked to have nasal mucosal biopsies done at baseline and between weeks 4 and 6.

Eligibility criteria:
inclusion criteria: 1. males and females ages 18 years or older 2. have a history of nasal obstruction 3. have failed a trial of topical steroids (that included at least 1 month of daily use) 4. ability to read, write, and understand english 5. either do not desire surgery or are poor surgical candidates due to medical comorbidities. 6. patients who have had prior use of oxymetazoline or other nasal decongestants are eligible for the study but must have stopped usage 4 weeks prior to randomization. 1. must be willing to stop using any other nasal sprays, besides saline, and oral decongestants. exclusion criteria: 1. any history of sinonasal mass/tumor 2. any history of nasal polyps 3. a known history of chronic sinusitis 4. an allergy to oxymetazoline 5. or who have any medical contraindication to oxymetazoline use, such as pulmonary hypertension.

Keywords: oxymetazoline corticosteroids chronic rhinitis
study of testosterone vs placebo in testicular cancer survivors

Conditions: Metabolic Syndrome; Testicular Cancer; Leydig Cell Failure in Adult

Summary: the overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild leydig cell insufficiency in order to reduce the risk of cardiovascular disease. the primary study objective is to evaluate changes in insulin sensitivity. the secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.

this is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild leydig cell insufficiency. 70 subjects will be randomized to receive either testosterone replacement therapy or placebo. the subjects will be invited for an information meeting where informed consent is signed. if a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. dose adjustment will be made three times during the first 8 weeks of the study. evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).

Eligibility criteria:
inclusion criteria: * signed informed consent. * previous treatment for testicular cancer. * no signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy). * free testosterone \ -2 standard deviations (sd) from the age-adjusted median and lh \> 2 sd from the age-adjusted median. exclusion criteria: * treatment with testosterone within the last 6 months. * contraindications to testosterone treatment (prostate cancer, prostate specific antigen (psa)\> 4 ng/ml), malignancy suspect prostate by digital rectal examination, alanine aminotransferase (alt)\> 1.5 upper reference level, erythrocyte volume fraction (evf) \> 50%. * breast cancer. * symptomatic obstructive sleep apnoea syndrome * heart failure \> nyha ii. * uncontrolled hypertension: (systolic blood pressure \> 160 mm hg despite antihypertensive treatment, measured at two separate occasions) * inability to understand information about the trial * participation in any other clinical trial * allergy for the active substance or additives in tostran or placebo. * known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.
a model for implementation of cervical cancer screening and hpv vaccination the emergency department: a pilot study

Conditions: Genital Human Papilloma Virus Infection

Summary: in this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, hpv 16/18 and/or cytology) are presenting to the ed, cytology/ hpv testing via thinprep®pap testtm and surveillance. we intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study. females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the thin prep® cytology test. this study will allow surveillance of disease through cytology and hpv dna testing via collection of data using thin prep® cytology with reflex hpv dna testing according to established guidelines as described below. provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. patients will receive first vaccine in the ed and will have arranged follow up for administration of the 2 month and 6 month series of the hpv vaccination. through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..


Eligibility criteria:
inclusion criteria: * 3 years of beginning sexual activity or by age 21 years whichever occur first. * resident of the city of norfolk, virginia * uninsured exclusion criteria: * pregnant women * women with hysterectomy with cervical excision * women who received full hpv vaccine series * known history of cervical cancer * male sex * loop electrocautery excision procedure(leep) * cold-knife conization
study of erenumab (amg 334) in women with hot flashes

Conditions: Vasomotor Symptoms; Hot Flashes

Summary: the primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (amg 334) in women with hot flashes associated with menopause.

this study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (dbf) provides a good model for the vasodilation associated with hot flashes; therefore erenumab doses that cause dbf inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of hfs.

Eligibility criteria:
inclusion criteria: * female subjects with hot flashes associated with menopause between 45 and 65 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the amgen physician. exclusion criteria: * history or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the investigator or amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Keywords: vasomotor symptoms; hot flashes; menopause
a study of ly3321367 alone or with ly3300054 in participants with advanced relapsed/refractory solid tumors

Conditions: Solid Tumor

Summary: the purpose of this study is to evaluate the safety of the study drug known as ly3321367, an anti-t-cell immunoglobulin and mucin-domain domain-containing molecule-3 (tim-3) antibody administered alone or in combination with ly3300054, an anti-programmed death ligand 1 (pd-l1) antibody, in participants with advanced relapsed/refractory solid tumors.


Eligibility criteria:
inclusion criteria: * for ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor. * for phase 1a and 1b, prior pd-1 or pd-l1 therapy or other immunotherapy is allowed, if the following criteria are met: * must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. * must have completely recovered or recovered to baseline prior to screening from any prior aes occurring while receiving prior immunotherapy. * must have provided tumor tissue sample, as follows: * for participants entering ph1a: have submitted, if available, an archival tumor tissue sample. * for participants entering ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (ph1b). * must have a performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale. * must have adequate organ function. * have an estimated life expectancy of 12 weeks, in judgement of the investigator. exclusion criteria: * have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible). * have received a live vaccine within 30 days before the first dose of study treatment. * if female, is pregnant, breastfeeding, or planning to become pregnant. * have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation. * have moderate or severe cardiovascular disease. * have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including active or chronic infection with human immunodeficiency virus (hiv), active hepatitis b virus (hbv), active hepatitis c virus (hcv), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment. * use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). \[use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted\]. * bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection. * evidence of interstitial lung disease or noninfectious pneumonitis.

Keywords: tim-3 pd-l1
quitguide for american indians: aims 2 & 3

Conditions: Tobacco Use; Tobacco Use Disorder

Summary: aim 3: to test feasibility, acceptability, and preliminary efficacy of the tailored quitguide for smoking cessation among ais.


Eligibility criteria:
inclusion criteria: * american indian person based on self-report * age ≥ 18 years * interested in quitting smoking * smoke ≥ 3 commercial tobacco cigarette per day (cpd) in the past 30 days o use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product * smartphone ownership with the ability to download applications and sufficient data to complete research procedures exclusion criteria: * new or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler or medications chantix/wellbtrutin/zyban/bupropion) in past month * does not speak or read english
application of iced normal saline combined with cocktail perfusion in total knee arthroplasty

Conditions: Pain, Postoperative; Blood Loss, Postoperative

Summary: sixty patients undergoing tka were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. one way anova analysis on visual analogue scale (vas) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.

patients with confirmed primary knee osteoarthritis in stage iv by preoperative x-ray were included in present study, whilst subsequent arthritis (including rheumatoid arthritis, gouty arthritis, traumatic arthritis, etc.) were excluded. after assessment, sixty qualified patients who voluntarily participating in this study have understood the research project were included in the present study and the corresponding consent forms were signed. patients were randomly classified into three groups with different interventions, each group contains 20 patients. group a: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; group b twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. all the study personnel including the patients, their family members, the nursing staff and the leading operator were blind to the treatment allocation.

Eligibility criteria:
inclusion criteria: patients with confirmed primary knee osteoarthritis in stage iv by preoperative x-ray were included in present study. kellgren-lawrence radiology standards for stage iv were listed as follows: obviously narrowed joint space; vast osteophytes are formed; severe osteosclerosis under the cartilage; bone hypertrophy and evident deformity exclusion criteria: subsequent arthritis (including rheumatoid arthritis, gouty arthritis, traumatic arthritis, etc.) were excluded.
evaluation of l-alpha-acetylmethadol (laam) in methadone patients - 5

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to determine the pharmacokinetics of l-alpha-acetylmethadol (laam) in adults transferred from methadone maintenance treatment for opiate dependence.


Eligibility criteria:
please contact site for information.

Keywords: opiate dependence
ondissolve in the prophylaxis/rescue of radiation induced nausea and vomiting

Conditions: Nausea; Vomiting

Summary: the primary objective of the study is to examine the efficacy of ondissolve for the prevention/rescue of acute and delayed phase radiation induced nausea and vomiting (rinv) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. the study population will be 30 patients seen in the rrrp at the sunnybrook odette cancer centre receiving palliative radiation therapy considered emetogenic for bone metastases. patients will take the study medication (ondissolve 8 mg) twice on each day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8 hours later the same day. patients undergoing multiple fraction radiation therapy will take ondissolve on weekends or holidays in between treatment. secondary objectives include to evaluate key secondary endpoints related to rinv, and to investigate the ease and length of administration of protocol medicine. we hypothesize that ondissolve will be effective in the prophylaxis of rinv, and the ease of use and administration will provide an appropriate delivery method for those unable to tolerate the oral form of ondansetron.


Eligibility criteria:
inclusion criteria: * informed consent * patient will receive palliative radiation therapy considered emetogenic for bone metastases. * group 1: at least mild nausea and/or at least mild vomiting as recorded in the baseline nausea and vomiting data collection sheet * group 2: nausea and vomiting recorded as 'none' in the baseline nausea and vomiting data collection sheet exclusion criteria: * patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol rt. * patient received cranial rt within 7 days prior to commencement of protocol rt. * patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol rt. * patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol rt. * patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity within 48 hours of protocol rt. * patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity during or within 10 days following completion of protocol rt. * patient is allergic to protocol medication. * patient has a karnofsky performance status score \<40. * patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
sugammadex versus neostigmine for reversal of neuromuscular blockade at the end of kidney transplantation surgery

Conditions: Kidney Transplant; Complications; Postoperative Residual Curarization; Postoperative Residual Weakness

Summary: the purpose of this study is to compare two medications that reverse muscle paralysis at the end of kidney transplant surgery with the goal of reducing residual muscle weakness and insufficient respiratory function after surgery.

this is a prospective randomized double-blind single center study on patients with severe kidney failure undergoing kidney transplantation surgery. patients will have their muscles paralyzed during general anesthesia for surgery. at the end of surgery, muscle paralysis will be reversed with either neostigmine (control group) or sugammadex (intervention group). residual muscle weakness and respiratory function will be monitored after surgery with a quantitative train-of-four (qtof) monitor and a noninvasive continuous ventilation monitor. the investigators hypothesize that patients receiving sugammadex will have less residual muscle weakness and better respiratory function than patients receiving neostigmine. respiratory and kidney function parameters and any adverse events will be collected during the hospital stay. patients will contacted for a study follow up around 2 weeks after their surgery.

Eligibility criteria:
inclusion criteria: * at least 18 years or older * diagnosed with severe kidney dysfunction (defined by plasma creatinine clearance \<30 ml/min) * planning on kidney transplantation surgery at the university of colorado hospital. exclusion criteria: * patients unable to sign the informed consent * pregnant women * body mass index (bmi) \> 40 kg/m2 * pre-existing oxygen or ventilatory dependency (24h use of oxygen or other noninvasive or invasive ventilatory support) * patients with any pulmonary, neuromuscular or other disease that severely limits their respiratory functional status (e.g. unable to achieve 4 metabolic equivalent of tasks, mets, such as climbing up 1 flight of stairs) * presence of any contraindication for any of the study-related medications or interventions.
carboplatin, paclitaxel and tlk286 (telcyta) as first-line therapy in advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this trial is to study the efficacy and safety of the triplet combination of tlk286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * histologically confirmed non-small cell lung cancer (nsclc) * stage iv or iiib (disease that is not eligible for combined modality chemotherapy and radiation) * measurable disease by recist * ecog status of 0-1 * adequate liver and renal function * adequate bone marrow reserves exclusion criteria: * prior chemotherapy, immunotherapy or biologic therapy for metastatic nsclc * up to one prior adjuvant or neoadjuvant chemotherapy is allowed * history of bone marrow transplantation or stem cell support * pregnant or lactating women

Keywords: non-small cell lung cancer
safety and efficacy study of a dual pi3k delta/gamma inhibitor in t-cell lymphoma

Conditions: Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous

Summary: the purpose of this study is to evaluate the safety, pk and efficacy of rp6530, a dual pi3k delta/gamma inhibitor in patients with relapsed and refractory t-cell lymphoma.

safety: treatment-emergent ae; treatment-related ae, sae and clinical significant ae; dose limiting toxicities (dlt). pk: peak plasma concentration (cmax), area under the plasma concentration versus time curve (auc), time of maximum concentration observed (tmax). efficacy: overall response rate (orr), progression free survival (pfs), overall survival (os) and duration of response.

Eligibility criteria:
inclusion criteria: * histologically confirmed t cell non-hodgkin lymphoma (t-nhl) * refractory to or relapsed after at least 1 prior treatment line. * ecog performance status ≤2 * patients must be ≥18 years of age * able to give a written informed consent. exclusion criteria: * any cancer therapy in the last 3 weeks or limited palliative radiation \<2 weeks * patients with hbv, hcv or hiv infection * previous therapy with gs-1101 (cal-101, idelalisib), ipi-145 (duvelisib), tgr-1202 or any drug that specifically inhibits pi3k/ mtor (including temsirolimus, everolimus), akt or btk inhibitor (including ibrutinib) in last 6 months * patients on immunosuppressive therapy including systemic corticosteroids. * patients with known history of liver disorders. * patients with uncontrolled diabetes type i or type ii * any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * women who are pregnant or lactating.

Keywords: ctcl ptcl rp6530